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Clinical Outcomes Solutions logo
Clinical Outcomes Solutions

A global research consulting group providing 360° support & services across all facets of clinical outcomes research.

Senior Statistical Programmer, FSP

Software EngineerSoftware EngineerFull TimeRemoteSeniorTeam 51-200H1B SponsorCompany SiteLinkedIn

Location

Colombia

Posted

69 days ago

Salary

0

Seniority

Senior

Bachelor Degree8 yrs expEnglish

Job Description

Senior Statistical Programmer, FSP

Clinical Outcomes Solutions

• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming • Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs) • Production and QC / validation programming • Generating complex ad-hoc reports utilizing raw data • Applying strong understanding/experience of Efficacy analysis • Creating and reviewing submission documents and eCRTs • Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries • Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc. • Being adaptable and flexible when priorities change

Job Requirements

  • Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
  • At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above.
  • Study lead experience, preferably juggling multiple projects simultaneously preferred.
  • Strong SAS data manipulation, analysis and reporting skills.
  • Solid experience implementing the latest CDISC SDTM / ADaM standards.
  • Strong QC / validation skills.
  • Good ad-hoc reporting skills.
  • Proficiency in Efficacy analysis.
  • Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
  • Submissions experience utilizing define.xml and other submission documents.
  • Experience supporting oncology or immunology studies would be a plus.
  • Excellent analytical & troubleshooting skills.
  • Ability to provide quality output and deliverables, in adherence with challenging timelines.
  • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.

Benefits

  • Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients.
  • Cytel provides consistent training, development and support.

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